DIPHENHYDRAMINE HYDROCHLORIDE 25MG- diphenhydramine hydrochloride 25mg tablet 
Strive Pharmaceuticals Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Nighttime Sleep-Aid
Sleep - Dormir
(Diphenhydramine HCl 25mg) - Blue caplet

Diphenhydramine HCl 25mg

croscarmellose sodium, D&C blue #4 aluminium lake, dibasic calcium phosphate, hydroxy propyl methyl cellulose, isopropyl alcohol, magnesium stearate, microcrystalline cellulose, polyethyl;ene glycol, talc, titanium dioxide

adults and children 12 years of age and over2 caplets at bedtime if needed, or as directed by a doctor
children under 12 years of agedo not use

for relief of occasional sleeplessness

Do not use

Ask a doctor before use if you have

Ask a doctor or a pharmacist before use if

you are taking sedatives or tranquilzers

When using this product

Stop use and ask a doctor if

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness

If pregnant or breast-feeding,

ask a health professional before use

Keep out of reach of children

Overdose warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Keep out of reach of children

Overdose Warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Nighttime sleep-aid

LB11101CT11101CT11141

DIPHENHYDRAMINE HYDROCHLORIDE 25MG 
diphenhydramine hydrochloride 25mg tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70692-111
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
D&C BLUE NO. 4 (UNII: 0KSY80VYS3)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
TALC (UNII: 7SEV7J4R1U)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
Product Characteristics
ColorblueScoreno score
ShapeCAPSULESize12mm
FlavorImprint Code S1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70692-111-414 in 1 PACKAGE; Type 0: Not a Combination Product12/20/2018
2NDC:70692-111-01100 in 1 PACKAGE; Type 0: Not a Combination Product01/29/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/20/2018
Labeler - Strive Pharmaceuticals Inc (080028013)

Revised: 11/2020
Document Id: b43d643e-eb34-b295-e053-2995a90a7b6f
Set id: 91e5bd4a-b981-5b26-e053-2a95a90af9fe
Version: 3
Effective Time: 20201116
 
Strive Pharmaceuticals Inc